Expanded Access to Nivolumab (Opdivo) for Patients with Limited Treatment Options
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT03126643
This program offers early access to the drug Nivolumab (Opdivo) for patients, especially children, with serious illnesses who have no other treatment options and may benefit from this medication.
Patient Parameters
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Program Overview
Bristol-Myers Squibb (BMS) is working with doctors to provide access to Nivolumab (Opdivo) for patients with life-threatening conditions who have tried all other treatments without success. This program is especially for pediatric patients with a high number of genetic mutations in their cancer, where there is a reasonable chance that the benefits of the drug outweigh the risks.
Description
Deciding to join an early access program for a new medication is a significant personal choice. It's important to discuss this option with your doctor, as well as with family or friends, to make an informed decision. If you want to learn more about how to access Nivolumab early, your doctor can reach out to Bristol-Myers Squibb (BMS) for more information.
Eligibility Criteria
Specific eligibility criteria must be met for access outside of a clinical trial.
These inclusion criteria include:
- The illness must be serious or life threatening
- There are no other viable options (including approved products or active clinical trials)
- There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks based on what is known at the time
- Other defined inclusion/exclusion criteria could be applicable.
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